Anesthesia, Epidural, Hypotension
Conditions
Brief summary
The purpose of this pilot trial is to examine the feasibility and ease of use of monitoring by ClearSight in laboring and delivering patients with the intent to compare time-to-treatment of hypotension between conventionally monitored patients (Group CM) and those receiving HPI (Group CM + HPI) monitoring by ClearSight, in a population of healthy laboring women who receive epidural analgesia.
Detailed description
In a prospective study, we will achieve the following aims: To determine the feasibility and ease of use of the ClearSight monitoring system in the labor-delivery room (LDR) in detecting and monitoring hypotensive events post-epidural labor analgesia placement. To compare the Time-to-Treatment of hypotensive events between the conventionally monitored patients (Group CM) and those receiving HPI (Group CM + HPI) monitoring by ClearSight.
Interventions
DIAGNOSTIC_TESTClearSight HPI Monitoring system
Continuous blood pressure monitoring for precision hypotensive event response
DIAGNOSTIC_TESTStandard of Care Blood Pressure Monitoring
Blood pressure (BP) monitoring using a conventional arm cuff and inflation after epidural anesthesia as standard procedure. Standard of care blood pressure monitoring includes measurement of blood pressure at the time of epidural test dose delivery, 3-minute cycles of BP monitoring for 30 minutes after epidural placement, and then BP monitoring every 15 minutes per existing clinical standards for at least 4-hours, or until delivery.
Sponsors
Edwards Lifesciences
Grace Lim, MD, MS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Masking description
Participants will wear both a conventional blood pressure cuff and the ClearSight finger cuff throughout the duration of the 4-hours post-epidural placement.
Intervention model description
Participants are randomized to receive standard clinical care (SCC) blood pressure measurement or blood pressure monitoring of HPI via ClearSight with SCC.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Pregnant * Age ≥ 18 years of age * Planning vaginal delivery * Receiving epidural labor analgesia (ELA)
Exclusion criteria
* Non-reassuring fetal tracing at the time of ELA request * Contraindications to ELA * Significant cardiac arrhythmias or aortic regurgitation * Arrhythmia * Treatment with antihypertensive medications * Pre-eclampsia with or without severe features * Preoperative infection * Inability to use ClearSight device for any reason * Non-English fluency * Sustains unintentional dural puncture * Incomplete data
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time-to-treatment of Hypotension (Minutes) | From epidural placement until 4-hours post-infusion start | The difference in time between diagnosis of hypotension and treatment by clinical staff between CM and HPI groups |
| Ease of Use by Clinical Staff | report at 4-hour post-infusion | Clinical nurse reports of ease of use of ClearSight device. This outcome will be measured on a Likert Scale (0-4) with the options being: 0-Completely Disagree, 1-Disagree, 2-Neither agree nor disagree, 3-Agree, 4-Completely Agree. Outcome measure will be reported as count of participant's responses per category. For this scale, the objective was to obtain agreeable response feedback (score of 3 or 4). The specific question to measure ease of use by clinical staff was: The ClearSight blood pressure monitoring device seems easy to use. |
| Ease of Hypotension Detection by Clinical Staff | report at 4-hour post-infusion | Clinical nurse reports of ease of hypotension detection using ClearSight device. This outcome will be measured on a Likert Scale (0-4) with the options being: 0-Completely Disagree, 1-Disagree, 2-Neither agree nor disagree, 3-Agree, 4-Completely Agree. Outcome measure will be reported as count of participant's responses per category. For this scale, the objective was to obtain agreeable response feedback (score of 3 or 4). The specific question to measure ease of use by clinical staff was: The ClearSight blood pressure monitoring device seems suitable. |
| Satisfaction of ClearSight Use by Clinical Staff | report at 4-hour post-infusion | Clinical nurse reports of satisfaction of use of ClearSight device. This outcome will be measured on a Likert Scale (0-4) with the options being: 0-Completely Disagree, 1-Disagree, 2-Neither agree nor disagree, 3-Agree, 4-Completely Agree. Outcome measure will be reported as count of participant's responses per category. For this scale, the objective was to obtain agreeable response feedback (score of 3 or 4). The specific question to measure ease of use by clinical staff was: The ClearSight blood pressure monitoring device meets my approval. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Ephedrine, mg | Epidural placement to 4-hours post-infusion start | Average ephedrine dose(s) given to patients in CM and CM+HPI groups |
| Total Intravenous Fluids, mL | Epidural placement to 4-hours post-infusion start | Average volume of fluids given to patients in CM and CM+HPI groups |
| Total Time in Hypotension With Mean Arterial Pressure (MAP) <65 mmHg (in Minutes) | Epidural placement to 4-hours post-infusion start | Average number of minutes patients spent within hypotensive events for each group (CM and CM + HPI). |
| Fetal Heart Rate Decelerations Within 1 Hour of Initiation of ELA | Epidural placement to 1-hour post-infusion start | Percentage of patients who experience any fetal heart rate deceleration event \[Presence (Yes) or absence (No)\] within 1-hour of epidural placement. |
| Total Number of Reported Changes in Fetal Heart Rate Category (From Healthy to Deceleration or Excelleration) | Epidural placement to 4-hours post-infusion start | Total number of participants who experienced changes in fetal heart rate category (any) |
| Nausea (Yes/No) | Epidural placement to 4-hours post-infusion start | Proportion of patients by group reporting nausea within 4-hours of post-epidural placement |
| Vomiting (Yes/No) | Epidural placement to 4-hours post-infusion start | Proportion of patients by group reporting Vomiting within 4-hours of post-epidural placement |
| Total Phenylephrine, mg | Epidural placement to 4-hours post-infusion start | Average phenylephrine dose(s) given to patients in CM and CM+HPI groups |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Conventional Care Patients are wearing both a conventional blood pressure cuff and the ClearSight finger cuff blood pressure monitoring system. Only measures from the conventional blood pressure cuff are sent/received by the clinical staff in the central and local nursing and anesthesia staff areas. The ClearSight monitoring system data is collected but not used by the clinical staff team for hypotensive monitoring.
Standard of Care Blood Pressure Monitoring: Blood pressure (BP) monitoring using a conventional arm cuff and inflation after epidural anesthesia as standard procedure. Standard of care blood pressure monitoring includes measurement of blood pressure at the time of epidural test dose delivery, 3-minute cycles of BP monitoring for 30 minutes after epidural placement, and then BP monitoring every 15 minutes per existing clinical standards for at least 4-hours, or until delivery. | 14 |
| ClearSight Monitoring Patients are wearing both a conventional blood pressure cuff and the ClearSight finger cuff blood pressure monitoring system. Measures from BOTH the conventional blood pressure cuff and ClearSight monitoring system are sent/received by the clinical staff in the central and local nursing and anesthesia staff areas. ClearSight monitoring will add additional information regarding hypotensive events for clinical staff to respond to.
ClearSight HPI Monitoring system: Continuous blood pressure monitoring for precision hypotensive event response
Standard of Care Blood Pressure Monitoring: Blood pressure (BP) monitoring using a conventional arm cuff and inflation after epidural anesthesia as standard procedure. Standard of care blood pressure monitoring includes measurement of blood pressure at the time of epidural test dose delivery, 3-minute cycles of BP monitoring for 30 minutes after epidural placement, and then BP monitoring every 15 minutes per existing clinical standards for at least 4-hours, or until delivery. | 16 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Ineligibility criteria identified | 2 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Total | Conventional Care | ClearSight Monitoring |
|---|---|---|---|
| Age, Continuous | 29.6 years STANDARD_DEVIATION 5.5 | 29.4 years STANDARD_DEVIATION 5.5 | 29.8 years STANDARD_DEVIATION 5.7 |
| Body Mass Index | 33.7 kg/m^2 STANDARD_DEVIATION 5.8 | 32.4 kg/m^2 STANDARD_DEVIATION 5.1 | 34.9 kg/m^2 STANDARD_DEVIATION 6.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 25 Participants | 12 Participants | 13 Participants |
| Region of Enrollment United States | 30 participants | 14 participants | 16 participants |
| Sex: Female, Male Female | 30 Participants | 14 Participants | 16 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 16 |
| other Total, other adverse events | 0 / 14 | 0 / 16 |
| serious Total, serious adverse events | 0 / 14 | 0 / 16 |
Outcome results
Primary
Ease of Hypotension Detection by Clinical Staff
Clinical nurse reports of ease of hypotension detection using ClearSight device. This outcome will be measured on a Likert Scale (0-4) with the options being: 0-Completely Disagree, 1-Disagree, 2-Neither agree nor disagree, 3-Agree, 4-Completely Agree. Outcome measure will be reported as count of participant's responses per category. For this scale, the objective was to obtain agreeable response feedback (score of 3 or 4). The specific question to measure ease of use by clinical staff was: The ClearSight blood pressure monitoring device seems suitable.
Time frame: report at 4-hour post-infusion
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Conventional Care | Ease of Hypotension Detection by Clinical Staff | Disagree | 1 Participants |
| Conventional Care | Ease of Hypotension Detection by Clinical Staff | Completely Agree | 4 Participants |
| Conventional Care | Ease of Hypotension Detection by Clinical Staff | Neither agree nor disagree | 0 Participants |
| Conventional Care | Ease of Hypotension Detection by Clinical Staff | Agree | 9 Participants |
| ClearSight Monitoring | Ease of Hypotension Detection by Clinical Staff | Agree | 10 Participants |
| ClearSight Monitoring | Ease of Hypotension Detection by Clinical Staff | Disagree | 1 Participants |
| ClearSight Monitoring | Ease of Hypotension Detection by Clinical Staff | Neither agree nor disagree | 2 Participants |
| ClearSight Monitoring | Ease of Hypotension Detection by Clinical Staff | Completely Agree | 3 Participants |
Primary
Ease of Use by Clinical Staff
Clinical nurse reports of ease of use of ClearSight device. This outcome will be measured on a Likert Scale (0-4) with the options being: 0-Completely Disagree, 1-Disagree, 2-Neither agree nor disagree, 3-Agree, 4-Completely Agree. Outcome measure will be reported as count of participant's responses per category. For this scale, the objective was to obtain agreeable response feedback (score of 3 or 4). The specific question to measure ease of use by clinical staff was: The ClearSight blood pressure monitoring device seems easy to use.
Time frame: report at 4-hour post-infusion
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Conventional Care | Ease of Use by Clinical Staff | Disagree | 1 Participants |
| Conventional Care | Ease of Use by Clinical Staff | Neither agree nor disagree | 4 Participants |
| Conventional Care | Ease of Use by Clinical Staff | Agree | 6 Participants |
| Conventional Care | Ease of Use by Clinical Staff | Completely Agree | 3 Participants |
| ClearSight Monitoring | Ease of Use by Clinical Staff | Completely Agree | 4 Participants |
| ClearSight Monitoring | Ease of Use by Clinical Staff | Disagree | 1 Participants |
| ClearSight Monitoring | Ease of Use by Clinical Staff | Agree | 7 Participants |
| ClearSight Monitoring | Ease of Use by Clinical Staff | Neither agree nor disagree | 4 Participants |
Primary
Satisfaction of ClearSight Use by Clinical Staff
Clinical nurse reports of satisfaction of use of ClearSight device. This outcome will be measured on a Likert Scale (0-4) with the options being: 0-Completely Disagree, 1-Disagree, 2-Neither agree nor disagree, 3-Agree, 4-Completely Agree. Outcome measure will be reported as count of participant's responses per category. For this scale, the objective was to obtain agreeable response feedback (score of 3 or 4). The specific question to measure ease of use by clinical staff was: The ClearSight blood pressure monitoring device meets my approval.
Time frame: report at 4-hour post-infusion
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Conventional Care | Satisfaction of ClearSight Use by Clinical Staff | Disagree | 1 Participants |
| Conventional Care | Satisfaction of ClearSight Use by Clinical Staff | Completely Agree | 5 Participants |
| Conventional Care | Satisfaction of ClearSight Use by Clinical Staff | Agree | 7 Participants |
| Conventional Care | Satisfaction of ClearSight Use by Clinical Staff | Neither agree nor disagree | 1 Participants |
| ClearSight Monitoring | Satisfaction of ClearSight Use by Clinical Staff | Neither agree nor disagree | 3 Participants |
| ClearSight Monitoring | Satisfaction of ClearSight Use by Clinical Staff | Disagree | 0 Participants |
| ClearSight Monitoring | Satisfaction of ClearSight Use by Clinical Staff | Agree | 8 Participants |
| ClearSight Monitoring | Satisfaction of ClearSight Use by Clinical Staff | Completely Agree | 5 Participants |
Primary
Time-to-treatment of Hypotension (Minutes)
The difference in time between diagnosis of hypotension and treatment by clinical staff between CM and HPI groups
Time frame: From epidural placement until 4-hours post-infusion start
Population: Only subjects with a hypotensive event were analyzed for this outcome measure (n=20)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Care | Time-to-treatment of Hypotension (Minutes) | 21.8 minutes | Standard Deviation 17.5 |
| ClearSight Monitoring | Time-to-treatment of Hypotension (Minutes) | 23.1 minutes | Standard Deviation 17.6 |
Secondary
Fetal Heart Rate Decelerations Within 1 Hour of Initiation of ELA
Percentage of patients who experience any fetal heart rate deceleration event \[Presence (Yes) or absence (No)\] within 1-hour of epidural placement.
Time frame: Epidural placement to 1-hour post-infusion start
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Conventional Care | Fetal Heart Rate Decelerations Within 1 Hour of Initiation of ELA | Yes | 5 Participants |
| Conventional Care | Fetal Heart Rate Decelerations Within 1 Hour of Initiation of ELA | No | 9 Participants |
| ClearSight Monitoring | Fetal Heart Rate Decelerations Within 1 Hour of Initiation of ELA | Yes | 5 Participants |
| ClearSight Monitoring | Fetal Heart Rate Decelerations Within 1 Hour of Initiation of ELA | No | 10 Participants |
Secondary
Nausea (Yes/No)
Proportion of patients by group reporting nausea within 4-hours of post-epidural placement
Time frame: Epidural placement to 4-hours post-infusion start
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Conventional Care | Nausea (Yes/No) | Yes Nausea | 5 Participants |
| Conventional Care | Nausea (Yes/No) | No Nausea | 9 Participants |
| ClearSight Monitoring | Nausea (Yes/No) | Yes Nausea | 7 Participants |
| ClearSight Monitoring | Nausea (Yes/No) | No Nausea | 8 Participants |
Secondary
Total Ephedrine, mg
Average ephedrine dose(s) given to patients in CM and CM+HPI groups
Time frame: Epidural placement to 4-hours post-infusion start
Population: Only subjects with a hypotensive event and received epinephrine were analyzed for this outcome measure (n=19)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Care | Total Ephedrine, mg | 29.8 mg | Standard Deviation 26.4 |
| ClearSight Monitoring | Total Ephedrine, mg | 23.3 mg | Standard Deviation 23.6 |
Secondary
Total Intravenous Fluids, mL
Average volume of fluids given to patients in CM and CM+HPI groups
Time frame: Epidural placement to 4-hours post-infusion start
Population: Only subjects with a hypotensive event and received IV fluids were analyzed for this outcome measure (n=16)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Care | Total Intravenous Fluids, mL | 550.0 mL | Standard Deviation 169.6 |
| ClearSight Monitoring | Total Intravenous Fluids, mL | 535.7 mL | Standard Deviation 94.5 |
Secondary
Total Number of Reported Changes in Fetal Heart Rate Category (From Healthy to Deceleration or Excelleration)
Total number of participants who experienced changes in fetal heart rate category (any)
Time frame: Epidural placement to 4-hours post-infusion start
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Conventional Care | Total Number of Reported Changes in Fetal Heart Rate Category (From Healthy to Deceleration or Excelleration) | Yes - Changes in fetal heart rate | 8 Participants |
| Conventional Care | Total Number of Reported Changes in Fetal Heart Rate Category (From Healthy to Deceleration or Excelleration) | No - Changes in fetal heart rate | 6 Participants |
| ClearSight Monitoring | Total Number of Reported Changes in Fetal Heart Rate Category (From Healthy to Deceleration or Excelleration) | Yes - Changes in fetal heart rate | 6 Participants |
| ClearSight Monitoring | Total Number of Reported Changes in Fetal Heart Rate Category (From Healthy to Deceleration or Excelleration) | No - Changes in fetal heart rate | 9 Participants |
Secondary
Total Phenylephrine, mg
Average phenylephrine dose(s) given to patients in CM and CM+HPI groups
Time frame: Epidural placement to 4-hours post-infusion start
Population: Only subjects with a hypotensive event and received phenylephrine were analyzed for this outcome measure (n=9)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Care | Total Phenylephrine, mg | 223.3 mg | Standard Deviation 242.1 |
| ClearSight Monitoring | Total Phenylephrine, mg | 506.7 mg | Standard Deviation 410.5 |
Secondary
Total Time in Hypotension With Mean Arterial Pressure (MAP) <65 mmHg (in Minutes)
Average number of minutes patients spent within hypotensive events for each group (CM and CM + HPI).
Time frame: Epidural placement to 4-hours post-infusion start
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Care | Total Time in Hypotension With Mean Arterial Pressure (MAP) <65 mmHg (in Minutes) | 12.5 minutes | Standard Deviation 19.3 |
| ClearSight Monitoring | Total Time in Hypotension With Mean Arterial Pressure (MAP) <65 mmHg (in Minutes) | 7.7 minutes | Standard Deviation 9.5 |
Secondary
Vomiting (Yes/No)
Proportion of patients by group reporting Vomiting within 4-hours of post-epidural placement
Time frame: Epidural placement to 4-hours post-infusion start
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Conventional Care | Vomiting (Yes/No) | Yes Vomiting | 3 Participants |
| Conventional Care | Vomiting (Yes/No) | No Vomiting | 11 Participants |
| ClearSight Monitoring | Vomiting (Yes/No) | Yes Vomiting | 0 Participants |
| ClearSight Monitoring | Vomiting (Yes/No) | No Vomiting | 16 Participants |